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Data updated: Mar 10, 2026

NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE

NOREPINEPHRINE BITARTRATE
Cardiovascular Approved 2021-01-15
2
Indications
--
Phase 3 Trials
5
Years on Market

Details

Status
Prescription
First Approved
2021-01-15
Routes
INTRAVENOUS
Dosage Forms
SOLUTION

Companies

Active Ingredient: NOREPINEPHRINE BITARTRATE

NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE Approval History

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What NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE Treats

1 indications

NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE is approved for 1 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypotension
Source: FDA Label

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Key Completed Trials

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE FDA Label Details

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Indications & Usage

FDA Label (PDF)

Norepinephrine bitartrate injection is indicated to raise blood pressure in adult patients with severe, acute hypotension. Norepinephrine bitartrate injection is a catecholamine indicated for restoration of blood pressure in adult patients with acute hypotensive states.

NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE Patents & Exclusivity

Latest Patent: Mar 2041

Patents (15 active)

US12097170 Expires Mar 8, 2041
US12290494 Expires Mar 8, 2041
+ 5 more patents
Source: FDA Orange Book

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.